Trial Outcomes & Findings for RAPA-Keloid Study of Keloid Regression (NCT NCT04049552)

NCT ID: NCT04049552

Last Updated: 2021-09-29

Results Overview

Measurement of surface area of keloid

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 4 participants
• Primary outcome timeframe: Baseline to 6 months
• Results posted on: 2021-09-29

Participant Flow

Each subject enrolled was used as both active intervention and placebo, using 2 keloids on the same subject, color coded to have either rapamycin ointment or placebo ointment applied.

Unit of analysis: Keloids

Participant milestones

Measure	Overall Study Participants Rapamycin ointment will be applied to one keloid on the subject, and placebo will be applied to the second keloid on that subject. Keloids will be color coded to match either rapamycin ointment or placebo. Rapamycin 8% Ointment: A compounded ointment containing 8% rapamycin Placebo: Petrolatum ointment
Overall Study STARTED	4 8
Overall Study COMPLETED	3 6
Overall Study NOT COMPLETED	1 2

Reasons for withdrawal

Measure	Overall Study Participants Rapamycin ointment will be applied to one keloid on the subject, and placebo will be applied to the second keloid on that subject. Keloids will be color coded to match either rapamycin ointment or placebo. Rapamycin 8% Ointment: A compounded ointment containing 8% rapamycin Placebo: Petrolatum ointment
Overall Study Lost to Follow-up	1

Baseline Characteristics

RAPA-Keloid Study of Keloid Regression

Baseline characteristics by cohort

Measure	Overall Study Participants n=3 Keloids Rapamycin ointment will be applied to one keloid on the subject and placebo will be applied to a second keloid. Keloids will be color coded to match ointment applied Rapamycin 8% Ointment: A compounded ointment containing 8% rapamycin Placebo: Petrolatum ointment
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 6 months

Measurement of surface area of keloid

Outcome measures

Measure	RAPA Intervention n=3 keloids Rapamycin ointment will be applied to one keloid on the subject Rapamycin 8% Ointment: A compounded ointment containing 8% rapamycin	Placebo n=3 keloids Placebo will be applied as a control on one keloid on the subject Placebo: Petrolatum ointment placebo
Change in Keloid Surface Area	0.455 cm2 Interval 0.131 to 0.735	-0.039 cm2 Interval -0.09 to -0.0075

SECONDARY outcome

Timeframe: Baseline to 6 months

Measurement of height of keloid

Outcome measures

Measure	RAPA Intervention n=3 keloids Rapamycin ointment will be applied to one keloid on the subject Rapamycin 8% Ointment: A compounded ointment containing 8% rapamycin	Placebo n=3 keloids Placebo will be applied as a control on one keloid on the subject Placebo: Petrolatum ointment placebo
Change in Keloid Height Baseline	1.5 millimeters Interval 1.08 to 2.04	1.55 millimeters Interval 1.29 to 1.93
Change in Keloid Height 6 months	1.056 millimeters Interval 0.4 to 1.54	0.93 millimeters Interval 0.33 to 1.3

Adverse Events

RAPA Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dean L Kellogg Jr.

UT Health San Antonio

Phone: 210-617-5311

Email: kelloggd@uthscsa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place